MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR,PC,19CM, STAND KIT; DIALYSIS CATHETER

Model Number	5704150
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 02/2021).
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the guidewire allegedly unraveled.It was further reported another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the guidewire allegedly unraveled.It was further reported another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: per the complaint history review (chr), this is the only complaint reported for this lot number to date.A device history record (dhr) review is not required.Investigation summary: one guidewire was returned for evaluation.A gross visual evaluation was performed.The investigation is confirmed for unraveled/frayed guidewire, as the distal end of the guidewire was observed to be bent, stretched and frayed.The outer wrapping coil wire was unraveled distal to guidewire markers.An inner core wire could be seen protruding from the guidewire device distal to where the outer wrapping wire unraveling begins.Distal to the protrusion of the first inner, another inner wire could be seen protruding from the guidewire device.The portion of the second inner outside of the guidewire device had a j-shaped curve.A small portion of the wrapping outer wire at the very distal end of the guidewire device did not appear to be unraveled.There appeared to be blood/tissue residue at and near the boundary of the unraveling wrapping wire at the distal end of the guidewire device.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

• Brand Name: HEMOSPLIT, 14.5 FR,PC,19CM, STAND KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8941032
• Report Number: 3006260740-2019-02518
• Device Sequence Number: 2520732
• Product Code: MSD
• UDI-Device Identifier: 00801741012907
• UDI-Public: (01)00801741012907
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5704150
• Device Catalogue Number: 5704150
• Device Lot Number: RECP1322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1